Rocket R54569 PSU Operators Guide Rev 05 Aug 2016

Operators Guide

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Rocket Digital low vacuum/low flow Suction Pump – Operators Guide

OPERATORS GUIDE Rocket R54569 PSU Portable low vacuum/low flow Suction Pump

Rocket Digital low vacuum/low flow Suction Pump – Operators Guide

1. GENERAL ASSEMBLY

1. 2. 3. 4. 5. 6.

Carry Handle On/Off Button Control/Decision interface Back Lit LCD Screen Rotating lock for connection to chest drainage bottle. Single use filter cavity & filter detection

7. USB port & reset button indicated by

8. Power Supply Unit Connection port indicated by

Not Shown 9. Power Supply Unit Model: R54569-PSU-UK

10. Support cradle, for use during data transfer.

CAUTION: Any adjustment, modification or repairs to the equipment should only be carried out by authorised service agents.

WARNING: READ THIS MANUAL CAREFULLY: Please familiarise yourself with the contents of this manual before attempting to use the device. Failure to observe these instructions may result in damage to the pump or cause injury to the patient or user. This device should only be used by suitably qualified personnel

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Rocket Digital low vacuum/low flow Suction Pump – Operators Guide

2. GENERAL INFORMATION 2.1. COPYRIGHT This manual contains information that is subject to copyright. All rights reserved. This manual should not be photocopied, duplicated or distributed completely or in part without the approval of Rocket Medical plc.

2.2.MODEL NUMBERS: Suction Unit R54569. Power Supply R54569-PSU-UK Single Use Filter R54571

2.3. MANUAL REVISION: Revision 1: New Document Revision 2: Text update Revision 3: Addition of CE Mark and information for end user Revision 4: Text update Revision 5: Alarm & Software Update

2.4. MANUFACTURER: Rocket Medical plc Sedling Road WASHINGTON Tyne & Wear NE38 9BZ UK.

SERVICE AGENTS: Customer Services: Rocket Medical plc. Sedling Road. WASHINGTON. NE38 9BZ. ENGLAND Tel: +44(0)191 419 6988. Fax: +44(0)191 419 6989 Email: [email protected]

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Rocket Digital low vacuum/low flow Suction Pump – Operators Guide

2.5. GENERAL DESCRIPTION: The Rocket Digital low vacuum/low flow Suction unit (Known as the PSU, and referred to as the PSU for the purposes of this instruction manual) has been developed to provide low volume/low pressure suction via the Rocket Medical R54500, R54509 and R54517 Chest drain units. The system provides regulated negative pressure via the R54500, R54509 or R54517 (1800ml volume) chest drain bottles and R54502 or R54539 (12mm x 1500mm) connector tubing. Before and during use inspect the chest drainage bottle and connector tubing to ensure no damage has occurred. The R54500, R54509 and R54517 chest drainage bottles and R54502 or R54539 connector tubing are single use only. The range of suction is variable from -0.5 Kpa / -3.7mmHg/-5cmH2O to -5 Kpa / -37.5mmHg/-50 cmH2O*. *cmH2O is not a SI unit according to EU Directive 80/181/EEC. Treatment information is displayed graphically on the LCD screen in real time and when treatment has concluded, this information can be downloaded to a PC, using Rocket Medical software. Suction is applied to the chest drain unit, not directly to the pleural space. This is due to the underwater seal within the chest drainage unit. Adjustment may be required to levels of suction The PSU requires a disposable filter to be fitted to the chest drainage bottle and the suction unit before use. If no filter is fitted then the suction unit will not operate. The filter is supplied separately, sterile and for single use. The order code for the filter is R54571. The device is portable and can be operated independently of the mains supply. This is due to the rechargeable battery and thus this also allows patients to have suction applied to their chest drain unit even whilst they are mobile.

2.6. INTENDED USE To act as a device for the aspiration and removal of surgical fluids, tissue, gases, bodily fluids or infectious materials. PSU is indicated for drainage from the pleural and mediastinal cavity; which may include: post-operative management following cardiac surgery, pneumothorax, pleural effusion, empyema and other related conditions. This device should only be used by, or under the supervision of, appropriately trained personnel and in conjunction with current local clinical practice guidelines To only be used with a R54571 single use filter and R54500, R54509, R54517 chest drain units and tubing set (R54502, R54539).

2.7. CONTRAINDICATIONS: Not intended for use where a suction (vacuum) value of over 5 Kpa or a flow of over 5L/min is required. Not intended for use where the application of suction/vacuum to the pleural space is contraindicated or would place the patient at risk.

WARNING: Ensure the suction level is appropriate. Patients may experience discomfort when higher levels of suction are applied.

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Rocket Digital low vacuum/low flow Suction Pump – Operators Guide

2.8.CLASSIFICATION EN 60601-1:2006 Type of protection against electric shock: Class II Degree of protection against electric shock: Type B Vacuum type: low vacuum/low flow Suitable for continuous operation. Not suitable for use in the presence of flammable gases. Not suitable for use in conditions which expose the device to the ingress of fluids. Not suitable for sterilisation

WARNING: Protect the device from ingress of liquid. Should any liquid enter the device, discontinue use immediately and refer to an authorised service agent

WARNING: Device can cause explosion in the presence of flammable gases.

2.9 SPECIFICATIONS Power Input to Pump: 18VDC Power Supply: 100 - 240VAC 50/60Hz Consumption: 0.096 KW/h Frequency: 50/60 Hz Maximum current: 2.5A @ 18V Environmental conditions: +5°C to +35°C Service interval: 500 Battery charges Dimensions: • W - 190mm • H - 118mm • D - 140mm Weight: • Unit - 0.96Kg Suction Ranges: • User Set: -0.5Kpa to -5Kpa Suction Range Accuracy: ±10% at 2.5Kpa.

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Rocket Digital low vacuum/low flow Suction Pump – Operators Guide

3. SAFETY INSTRUCTIONS This manual describes the operation and intended use of the device and the associated consumables and it is essential that you use this document to familiarise yourself with the correct function and operation of the device before use. This device should only be used by, or under the supervision of, appropriately trained personnel and in conjunction with current local clinical practice guidelines. Failure to follow these instructions may result in serious injury to the patient or operator and can lead to damage or breakdown of the device. The Rocket R54569 Digital low vacuum/low flow Suction Unit is EMC tested in conformity with the requirements of EN 60601-1-2:2007 and can be used in the vicinity of other EMC tested devices that fulfil the requirements outlined in the EN 60601-1-2:2007 standard. Additional equipment connected to medical electrical equipment must comply with the respective IEC or ISO standards. Furthermore all configurations shall comply with the requirements for medical electrical systems. Anybody connecting additional equipment to medical electrical equipment configures a medical system and is therefore responsible that the system complies with the requirements for medical electrical systems. Local laws take priority over the above requirements. If in doubt consult your local representative or the service agents. Please note these instructions for use are a general guide for the use of the product, clinical matters must be addressed by qualified personnel.

3.1. POWER SUPPLY AND BATTERY OPERATION: The PSU can be operated from the mains power supply or with the inbuilt battery (Rechargeable Lithium-Ion 14.4V nominal, capacity approx. 2250mAh – Type 4SP1 4 cell 34Wh). The battery is charged on mains operation. Battery duration is dependent on the run time of the PSU. This is influenced by the extent of the parenchymal leakage and the set suction level. PSU does not run continuously but only switches on when the actual and nominal values differ. During continuous battery operation, Rocket Medical guarantees a minimum run time of 4 hours, after the battery has been fully charged. In practical operation the battery operating time is > 10 hours.

WARNING: The device is only for use with supplied power supply unit: Model Number: R54569-PSU-UK.

CAUTION: Disconnection from the mains supply can be achieved with the removal of the mains power lead from the power supply connection port of the device itself or from the wall socket.

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Rocket Digital low vacuum/low flow Suction Pump – Operators Guide

3.2. CONSUMABLES:

WARNING: This device must only be operated with approved consumables.

The device must only be used with a R54571 single use filter and only be used in conjunction with R54500, R54509 and R54517 chest drain units (capacity 1800ml) and tubing set (R54502, R54539). The suction unit will not operate if a filter set is not in situ. The filter sets are designed to prevent fluid contamination of the suction pump. If there is any evidence that the pump may have become contaminated with fluid or a solid during use or the filter has failed in any other way, it must be removed from service and returned for examination immediately. Please contact your nearest service centre for advice. Customer Services: Rocket Medical plc. Sedling Road. WASHINGTON. NE38 9BZ. ENGLAND Tel: +44(0)191 419 6988. Fax: +44(0)191 419 6989 Email: [email protected]

3.3. TERMINOLOGY: Throughout this manual the term “suction” is used to denote the application of vacuum or negative pressure. The use of the term ‘suction’ is in observance of the requirements of the ISO6061-1 Standard as amended.

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Rocket Digital low vacuum/low flow Suction Pump – Operators Guide

3.4. WARNINGS:             

       

Users should be familiar with and adhere to all warnings, cautions and instructions for use that are labelled on the PSU device and included in the PSU User Manual. This device should only be used by, or under the supervision of, appropriately trained personnel and in conjunction with current local clinical practice guidelines. Not intended for use where a suction (vacuum) value of over -5 Kpa or a flow of over 5L/min is required. Not intended for use where the application of suction/vacuum to the pleural space is contraindicated or would place the patient at risk. Data transfer is not allowed during therapy. The PSU device is not approved for connection to any other device except the Rocket Medical R54571 single use filter and R54500 chest drain unit and tubing set (R54502, R54539). The R54500 chest drain unit and tubing set (R54502, R54539) are single use parts and their instructions for use must be followed at all times. The PSU device has not been tested for compatibility with Magnetic Resonance Imaging (MRI) equipment and should not be introduced to an MRI scanning room. The device is not suitable for use during bathing or showering. Do not use in an area where flammable gases are present. If a persistent air leak is shown, check the filter is positioned correctly on the chest drain unit and that the suction unit is securely attached to the chest drain unit. Regular periodic maintenance of the PSU device is recommended and as a minimum should be undertaken annually. Precautions for EMC safety should be observed. The PSU complies with IEC60601-1-2:2007, however: - Electronic equipment in the vicinity of the PSU device may affect its operation and potentially cause unpredictable operation of the device. - Wherever possible the PSU device should be distanced from surrounding electromagnetic equipment and cables to this equipment in order to reduce possible electromagnetic interference. - The PSU device power cable should only be connected to a correctly wired grounding receptacle in order to avoid the risk of electrical shock. When positioning the unit, ensure that access is available to the DC power cable located on the rear of the unit. To avoid damage to the unit only use the approved mains power adaptor supplied with the unit, Model Number: R54569-PSU-UK. The PSU contains a Li-ion battery and that is not user replaceable and that unauthorised attempts to repair could lead to damage to the unit, environment and/or human health if incorrectly fitted, handled or disposed of improperly. The Li-ion battery must only be replaced by a suitably trained and Rocket Medical approved service centre. Fluids should not be allowed to enter the device as this may result in damage to the system. User should be aware of the status of unit at all times during the procedure. Only qualified personnel should service the device and the unit cabinet should not be opened except by these personnel due to the risk of hazardous electrical shock. All service requirements should be referred to a PSU authorised representative. All equipment should be thoroughly cleaned after each use (refer to section 7 Cleaning Guidelines).

WARNING: Do not modify this equipment without written authorization of the manufacturer.

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Rocket Digital low vacuum/low flow Suction Pump – Operators Guide

3.5. SUPPLY VOLTAGE SELECTION The device operates at a voltage of 18VDC supplied via a medical grade power supply unit (PSU). Rocket Model Number: R54569-PSU-UK Input voltage: 18VDC Power supply range 100 - 240VAC 50/60Hz. Ensure that only the supplied power supply cord is connected.

WARNING:ELECTRIC SHOCK HAZARD. This device is only for use with electrical systems complying with the appropriate IEC, CEC and NEC requirements.

3.6. ELECTROMAGNETIC COMPATIBILITY The PSU complies with the electromagnetic compatibility (EMC) limits for medical devices as specified by EN 606011-2:2007. These limits are designed to provide a reasonable degree of protection against harmful interference found in typical medical installations. Medical electrical equipment requires special precautions regarding EMC and the device must be installed, positioned and operated according to the instructions contained in this manual to ensure continued electromagnetic compatibility. It is possible that high levels of radiated or conducted radio-frequency electromagnetic interference (EMI) from portable and mobile RF communications equipment or other strong or nearby radio-frequency sources could result in performance disruption of the suction pump. Evidence of EMC interference may include erratic digital displays, an inability to correctly set the desired suction, the device failing to operate, or other incorrect functioning. If this occurs, stop using the aspiration pump and contact Customer Services or Rocket Medical authorised distributor.

3.7. PACKAGING The packaging has been carefully designed to allow secure transportation of the PSU and its accessories. After unpacking, re-assemble and retain the packaging for transport for servicing when required.

3.8. POSITIONING and PLACEMENT of the DEVICE The PSU must be placed securely on a R54500, R54509 or R54517 Chest drainage bottle, away from sources of heat, water splashes, mists or cooling vents and with due regard to EMC protection (Section 4.6)

WARNING: ELECTRIC SHOCK HAZARD. Do not immerse the device.

Do not expose to direct sunlight. Do not expose to flammable gases. Operating temperature Range: +5°C to +40°C

WARNING: Device can cause explosion in the presence of flammable gases.

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Rocket Digital low vacuum/low flow Suction Pump – Operators Guide

3.9. Symbols used on the PSU Unit.

On/Off

Read the manual before connection and use

This device is Type B

USB Port

DC power connection point. This device operates on 18V DC power provided by a separate power supply module supplied with the device. Disconnection from the mains supply can be achieved with the removal of the mains power lead from the power supply connection port of the device itself or from the wall socket Dispose of this device in accordance with WEEE directive (2002/96/EC)

CE Mark

Class II Device

Li-ion Battery used in the device

RESET

Reset button

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Rocket Digital low vacuum/low flow Suction Pump – Operators Guide

3.10. Symbols used on the PSU Screen

Confirm choice

Cancel Choice

Increase

Decrease

Warning

Battery Charging

Battery level of charge indication

Screen number (from 1-4)

Unit of measurement Can also be cmH2O and mmHg

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Rocket Digital low vacuum/low flow Suction Pump – Operators Guide

3.11. Symbols used on the Power Supply Unit. Read the manual before connection and use

WARNING: Risk of electric shock. The PSU should not be opened

Device is only for use indoors

Class II Power Supply Unit

18V DC connection polarity

Dispose of this device in accordance with WEEE directive (2002/96/EC)

PSU conforms to EN60601-1 & IEC60601-1:2006

CE Mark

3.12. Other Symbols used in the manual This symbol indicates to keep the device dry

This symbol indicates the temperature limitations for operation, transport and storage

This symbol indicates the humidity limitations for operation, transport and storage

This symbol indicates the atmospheric pressure limitations for operation, transport and storage

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Rocket Digital low vacuum/low flow Suction Pump – Operators Guide

4. INITIAL SET UP OF THE PUMP 4.1. Charge the Battery IMPORTANT: The suction unit battery is not charged. DO NOT CONNECT TO A PATIENT IMMEDIATELY UPON OPENING.

1. Remove all packaging for the device and the power supply. 2. Connect the correct mains lead to the 18V power supply module and connect to an electrical supply 100 240VAC 50/60Hz. The power supply module is self-regulating to generate 18VDC. 3. Connect the power supply to the PSU, the power supply connection port is on the back of the device. It is protected, and is behind the door marked 4. Charge the device for approximately. 3 hrs until the battery display is full.

IMPORTANT: The PSU may be connected to the power supply unit and remain in use while the battery is charging.

If the PSU is switched on and in use, the power supply unit may be disconnected at any time and the PSU will remain in use.

If the PSU is turned off while still connected to the power supply, the power supply MUST be disconnected before the PSU is switched on again.

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Rocket Digital low vacuum/low flow Suction Pump – Operators Guide

4.2.

When the battery is charged.

Press

and

hold

for longer than 2 seconds (s) to switch on the device.

A self-test will commence.

When the self-test has completed, follow the software instructions to set the time and date

When this has been completed turn the device off by pressing and holding

Press

for longer than 2s.

to shut down device.

WARNING: This device should only be used by, or under the supervision of, appropriately trained personnel and in conjunction with current local clinical practice guidelines Sterile accessories (Filter Unit R54751) packaging must be checked for integrity before use. The filter unit (R54571) is a single use device. This can be used for a maximum of 7 days.

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Rocket Digital low vacuum/low flow Suction Pump – Operators Guide

NOTE: The filter set is specially designed to prevent ingress of fluid to the pump. If the filter material becomes contaminated with fluid it will occlude thereby protecting the pump mechanism. Immediately replace the filter set if it becomes contaminated and the filter set MUST be changed between every patient. The pump must NOT be operated without the correct filter set attached. Operation without the correct filter set will invalidate the Warranty. Suction is applied to the chest drain unit, not directly to the pleural space. This is due to the underwater seal within the chest drainage unit. If the levels of fluid within the chest drain unit increase, adjustment may be required to increase levels of suction during treatment. The suction unit must be cleaned and disinfected between patient use, according to the Rocket cleaning guidelines.

The device is for use with and connection to the R54500, R54509 and R54517 chest drainage units only.

The chest drain unit must already be connected to the patient and checked to be in complete working order before the suction unit is attached.

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Rocket Digital low vacuum/low flow Suction Pump – Operators Guide

4.3. Attaching the filter 1. Remove the R54500, R54509 and R54517 chest drain bottle from its packaging. 2. Remove red bayonet sealing cap by rotating anti-clockwise from "CLOSE" to "OPEN" position. 3. Remove cap. 4. Fill bottle with fluid to prime level noted on label. 5. Open tubing package (R54502, R54539) and attach tubing set to bottle by inserting straw and cap into aperture and twisting clockwise until clicked shut. Take care not to touch the straw. 6. Once underwater seal has been established, place bottle on the floor and connect drainage catheter to tubing connector. 7. Then remove the Blue handle and the Green venting cap from the chest drain.

8. Unwrap the filter from packaging.

9. Place filter on to the suction port of the R54500, R54509 and R54517 Chest Drainage bottle.

10. Ensure when placing the filter the location peg is placed in the aperture which the green venting cap was in.

The PSU can now be attached to the chest drain bottle. 11. Rocket Electronic Suction Unit Filters are for single patient use for up to a maximum of 7 days.

CAUTION: If the filter is contaminated by fluid, the level of suction could be compromised. The filter is designed to protect the pump mechanism from fluid ingress. If contaminated, the filter set MUST be replaced immediately.

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Rocket Digital low vacuum/low flow Suction Pump – Operators Guide

4.4. Attaching the suction unit to the chest drain bottle Place the PSU over the filter unit, so the filter will fit in to the filter recess under the suction unit.

Place the PSU on to the chest drain unit. With slight downward pressure rotate the locking ring Anti-clockwise so that it locks into position.

4.5

Disconnecting the suction unit from the chest drain bottle

With slight downward pressure rotate the locking ring clockwise. To dispose of the R54500 Chest Drain Bottle 1. Remove tubing set for disposal in the usual manner by turning the clear plastic bayonet closure cap anticlockwise from "close" position to "open" position. 2. Remove the filter, tear/pull the red seal cap located on the bottle lid and marked seal, from its tether. 3. Push the red sealing cap firmly with a twisting action into the suction port on the lid of the bottle to seal. 4. Remove the red bayonet cap from its bracket on the side of the lid and replace in hole vacated by the tubing set. 5. Seal cap in place by rotating the cap clockwise from “open” to “close”. 6. Should the red bayonet cap be mislaid, do not remove tubing set, but cut through the tubing and place the end of the tubing over the suction port on the lid of the bottle to create a seal. 7. Bottle is now ready for disposal.

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Rocket Digital low vacuum/low flow Suction Pump – Operators Guide

5. OPERATING INSTRUCTIONS 1. Press device

for longer than 2s to turn the on.

The unit will begin a self-test If the self-test is unsuccessful see the trouble shooting instructions on page 24.

During the set you can confirm or cancel your decisions using the three buttons at the side of the screen.

2. Verify if the PSU is connected to a new patient.

This information is important for the data reading & recording. Yes – New patient number is issued. – Follow column A. No – Patient number is unchanged: Recommended for continued treatment of the same patient. Data recording is continued. – Follow column B.

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Rocket Digital low vacuum/low flow Suction Pump – Operators Guide

A If you press next screen.

B you will progress to the If you press

you will be asked to confirm if you

need to change the filter.

Please verify that you have changed the filter by

pressing

to confirm your decision.

If you have changed the filter press be taken to the next set up screen.

and you will

If you press you will be taken to the next set up screen. If the filter requires replacing press you will asked to change the filter and the unit will be shut down.

If you press you will be asked to change the filter and the unit will shut down.

Remove the suction unit and change the filter as per the instructions, re-fit the PSU to the chest drain bottle and switch on the unit again to restart the set up process .

Remove the suction unit and change the filter as pyer the instructions, re-fit the PSU to the chest drain bottle and switch on the unit again to restart the set up process.

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Rocket Digital low vacuum/low flow Suction Pump – Operators Guide

3. Confirm your unit of measurement. The PSU can measure – ve pressure in KPa, cmH2O and mmHg.

4. You will be asked to confirm your decision.

5. Set the amount of suction required. Using increase or decrease buttons until you are at a level you deem satisfactory. The levels suction applied increase in -0.5KPa, -5cmH2O and 3.75mmHg increments.

When you are happy with the set level of suction press

6. You will be asked to confirm your decision.

If you press of measurement.

you will be taken back to the previous screen where you can confirm your preferred unit

Pressing AND holding unit and to the patient.

for over 2 seconds will commence the application of suction to the chest drain

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Rocket R54569 PSU Operators Guide Rev 05 Aug 2016